Avie A1C Test System

FDA 510(k) K093548 · Mec Dynamics Corp

Substantially Equivalent

510(k) numberK093548

Submission

Device name
Avie A1C Test System
Applicant
Mec Dynamics Corp
San Jose, CA, US
Received
November 17, 2009
Decision date
July 20, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LCP – Assay, Glycosylated Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7470
Specialty
Hematology

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K180509Quo-Test A1c SystemLCP · Dual Track Ekf-Diagnostic GmbH02/16/2019SE
K173127skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…LCP · Traditional Skyla Corporation H.S.P.B09/25/2018SE
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More from Alfa Wassermann Diagnostic Technologies, LLC

510(k)DeviceDecision
K121752Avie Total HB Test SystemGKR · Traditional 01/07/2013SE
K091400Modification to Avie A1C Test SystemLCP · Special 06/11/2009SE
K081269Avie A1C Test SystemLCP · Traditional 03/20/2009SE

Questions and answers

When was Avie A1C Test System cleared by the FDA?

Avie A1C Test System (K093548) received a 510(k) decision of Substantially Equivalent on July 20, 2011, 610 days after the submission was received.

What is the product code of K093548?

The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.